Device for determination of an analyte in a body fluid

a technology for body fluids and analytes, which is applied in the direction of analytical using chemical indicators, laboratory glassware, instruments, etc., can solve the problems of end users, contamination of meter, and limitations of the technology embodied in the products developed to da

Inactive Publication Date: 2001-08-07
ROCHE DIABETES CARE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The technologies embodied in the products which have been developed to date have certain limitations from the perspective of the end user and / or the manufacturer.
Colorimetric strips that dose on the meter can lead to contamination of the meter.
Further, many patients with arthritis or vision impairment have difficulty bring a drop of blood which is hanging on one of their fingers to a small application spot on the strip in the meter.
Dosing off the meter, placing the sample on the strip and then inserting it into the meter, also can still lead to contamination.
Electrochemical strips deal with the contamination issues, but the manufacturing difficulties and cost can be prohibitive.
The issue of hematocrit level affecting the accuracy of test results is a substantial one for a test device.

Method used

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  • Device for determination of an analyte in a body fluid
  • Device for determination of an analyte in a body fluid
  • Device for determination of an analyte in a body fluid

Examples

Experimental program
Comparison scheme
Effect test

example a

ents

Reagent 1a

40 mg MBTH-S

80 mg DMAB

5 ml acetonitrile and 5 ml water

Stir until all solids are dissolved.

Reagent 2a

6 ml water

10 mg EDTA, disodium salt

200 mg PolyPep, low viscosity (Sigma)

0.668 g sodium citrate

0.523 g citric acid as a hematocrit adjuster

0.2 M Aconitic acid buffer

3% polyethylene glycol (PEG), as a separating agent

0.5% Polyquart, a binder

2.0 ml 6 wt % Gantrez AN-139 dissolved in water (GAF)

30 mg horseradish peroxidase, 100 units / mg, and 3.0 glucose oxidase, 2000 units / ml

Stir until dissolved.

example b

ents

Reagent 1b

20 ml water

420 mg citric acid (a buffering agent). Adjust the pH of the citric acid solution with NaOH to a value of 4.25.

16.7 mg EDTA

90 mg Gantrez S95 available from GAF

250 mg Crotein SPA

20,500 units glucose oxidase

16,200 units peroxidase

Reagent 2b

10 ml of a mixture of 3 parts by volume water and 7 parts by volume isopropyl alcohol

13 mg MBTH-S

40 mg ANS

Polyethersulfone Matrix

A piece of polyethersulfone membrane is uniformly coated with reagent la; the excess is squeegied off and the material is dried. The membrane is then coated with reagent 2a in the same fashion and dried. The membrane is then assembled into a test device as shown in FIG. 1. Whole blood is applied to the capillary opening and the glucose level is read from the front based on the indicator response in the test zone.

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Abstract

A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

Description

The present invention relates to a test device and determination of a chemical or biochemical component (analyte) in an aqueous body fluid, such as whole blood. In particular the present invention relates to a dry reagent test strip from which an analyte presence and / or concentration is determined by use of an instrument. A common use of such test strips is for determination of glucose level in blood by diabetics.BACKGROUND OF INVENTIONNumerous devices have been developed to test for presence and quantity of analytes in aqueous samples, such as whole blood or urine. The patent and technical literature of the last thirty years is replete with inventions which utilize a reagent strip containing a dry chemistry reagent system, that is, a system in which the wet chemistries are imbibed into an absorbent or bibulous medium, dried, and later reconstituted by fluid from the test sample. The reagent strips contain an indicator which changes color, depending on the presence or concentration ...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): B01L3/00G01N33/52G01N31/22
CPCB01L3/5023G01N33/525G01N33/521B01L2200/026B01L2200/0605B01L2300/0825B01L2300/0887B01L2400/0406Y10S436/805Y10S435/81Y10S435/97Y10S435/805Y10S436/81
Inventor DOUGLAS, JOEL S.RADWANSKI, RYSZARDDUCHON, BRENT G.PRIEST, JOHN H.HASKER, DAVID A.GLEISNER, JOHN M.
Owner ROCHE DIABETES CARE INC
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